WO1996039946A1 - Wound closure device - Google Patents

Wound closure device Download PDF

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Publication number
WO1996039946A1
WO1996039946A1 PCT/US1996/007318 US9607318W WO9639946A1 WO 1996039946 A1 WO1996039946 A1 WO 1996039946A1 US 9607318 W US9607318 W US 9607318W WO 9639946 A1 WO9639946 A1 WO 9639946A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
sheath
surgical device
distal end
actuator
Prior art date
Application number
PCT/US1996/007318
Other languages
French (fr)
Inventor
Philippe Poncet
Original Assignee
Raychem Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Raychem Corporation filed Critical Raychem Corporation
Priority to JP50062997A priority Critical patent/JP3729861B2/en
Priority to DE69622969T priority patent/DE69622969T2/en
Priority to AT96916518T priority patent/ATE222076T1/en
Priority to EP96916518A priority patent/EP0774922B1/en
Publication of WO1996039946A1 publication Critical patent/WO1996039946A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B17/2909—Handles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/047—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0472—Multiple-needled, e.g. double-needled, instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A61B2017/06019—Means for attaching suture to needle by means of a suture-receiving lateral eyelet machined in the needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A61B2017/06042—Means for attaching suture to needle located close to needle tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B2017/06085—Needles, e.g. needle tip configurations having a blunt tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0801—Prevention of accidental cutting or pricking
    • A61B2090/08021—Prevention of accidental cutting or pricking of the patient or his organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30092—Properties of materials and coating materials using shape memory or superelastic materials, e.g. nitinol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A61F2210/0019—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation

Definitions

  • This invention relates to a surgical instrument for closing the edges of a wound together with surgical sutures.
  • Minimum invasive surgery generally includes the creation of trocar puncture wounds through the abdominal wall of a patient for insertion of a variety of surgical instruments.
  • the structural strength of the abdominal wall is derived mostly from one or more layers of fascia disposed beneath the skin and between layers of muscle. Unless closed properly, the abdominal contents may herniate through these wounds, or body fluids can accumulate, promoting infection.
  • surgeons attempt to close trocar puncture wounds using conventional needle drivers which are often cumbersome, making it difficult to properly close the wound.
  • U.S. Patent No. 5,403,328 to Shallman describes a surgical apparatus for closing a trocar incision.
  • the Shallman device includes a curved needle pivotally positioned within a casing.
  • the mechanism for pivoting the needle of Shallman is somewhat cumbersome, even while deflection of the needle is limited, and requires a long stroke to manipulate the needle.
  • the present invention is a needle assembly in which the needle is constructed of a spring-like material and initially housed within a sheath in a deformed condition.
  • the needle can be easily exposed by sliding an actuator so as to release constraining means and allow the needle to assume its undeformed condition.
  • the needle assembly has few parts, allows a wide range for deflection of the needle, and the needle may be exposed with a relatively short stroke.
  • a first aspect of the invention comprises a surgical device for suturing a wound in the tissue of a patient comprising: a sheath having a longitudinal axis including a proximal end and a distal end; a recess formed in the wall of said sheath toward said distal end; a needle constructed of a spring-like material, said needle being movable from a first retracted position wherein said needle is withdrawn into said recess to a second exposed position wherein said needle is extended from said recess; means for constraining said needle in its retracted position by deforming said needle; an actuator at said proximal end of said sheath for releasing said constraining means, so as to thereby allow said needle to assume its undeformed condition and move to said exposed position; said needle having a configuration such that upon extension from said distal end of said sheath, said needle points in the direction of said proximal end.
  • a further aspect of the invention comprises a surgical device for suturing a wound in the tissue of a patient comprising: a sheath having a longitudinal axis including a proximal end and a distal end; a recess formed in the wall of said sheath toward said distal end; a needle constructed of a shape memory alloy material comprising a generally S- shape and including a body and having one end fixedly attached to the interior of the distal end of said sheath, the body of said needle being movable in said sheath from a first position wherein said needle is retracted into said recess to a second position exposed wherein said needle is extended laterally from said recess; means for constraining said needle in its retracted; an actuator at said proximal end of said sheath for releasing said constraining means, said actuator comprising: a sleeve slidable within said sheath; an opening formed in the distal end of said sleeve through which said needle extends in the exposed position;
  • Fig. 1 is a perspective view of the present invention.
  • Fig. 2 is an exploded view of device of Fig. 1.
  • Figs. 3a, 3b and 3c are schematic views of deployment of the present invention.
  • Figs. 4a, 4b and 4c are schematic views of a second embodiment of the present invention.
  • Fig. 1 illustrates a surgical device in the form of a puncture closure device 2 including a needle 4 movable in sheath 6.
  • An actuator 8 is capable of moving needle 4 from a first, retracted position, as seen in Fig. 3a, to a second, exposed position, as seen in Figs. 1 and 3c.
  • Device 2 is designed to be used in a sterile surgical field.
  • the device may be disposable or reusable or partially disposable or reusable.
  • the outer radial dimension of device 2 is 10mm or less.
  • Sheath 6 is a tubular sheath having a proximal end 10 and a distal end 12 disposed along opposite ends of longitudinal axis 14. Sheath 6 includes a blunt tip 16 located at the distal end and a gripping section 18 located at the proximal end.
  • the advantage of a blunt end is to eliminate risk of inadvertent puncture of organs or tissue when inserting the device into a wound.
  • a recess 20 is formed in the wall of the sheath adjacent to blunt tip 16 through which needle 4 may be extended, as seen in the Figures and as discussed below.
  • Needle 4 includes a body having a generally S-shaped configuration.
  • a first end 22 of needle 4 is fixedly attached to the interior of the distal end of the sheath. Needle 4 may be fixedly attached to sheath 6 at end 22 by pins or other mechanical attachment, or may be formed with the sheath.
  • the end opposite first end 22 of needle 4 is manipulation end 24, which includes a straightened portion 26. It should be noted, however, that the manipulation end may include a curved portion, rather than straightened portion 26.
  • Needle 4 is constructed of a spring-like material. In its undeformed configuration, needle 4 assumes its S-shaped configuration exposed so that the S-shape extends from fixed end 22 through recess 20 to manipulation end 24. Straightened portion 26 is then generally parallel to longitudinal axis 14.
  • the needle In its deformed configuration, the needle is confined within recess 20. Needle 4 moves from its retracted position to its exposed position by operation of actuator 8. When manipulation end 24 is retracted within recess 20, puncture closure device 2 is in its retracted position. When the manipulation end is extended from recess 20, the puncture closure device is in the exposed position.
  • needle 4 may be constructed of a spring-like material, such as a shape memory alloy or stainless steel.
  • the material be sufficiently resilient and bio-compatible.
  • the needle is preferably constructed of a shape memory alloy, more preferably of superelastic material, and most preferably of an alloy including nickel titanium.
  • shape memory alloys the radius of curvature of the S-shape can be smaller than with conventional materials, thereby permitting construction of a needle which has a configuration in which the manipulation end of the needle may be a greater distance from the sheath and in which the length of the S-shaped needle may be shorter.
  • Actuator 8 includes a sleeve 28 slidable within sheath 6.
  • the proximal portion of the sleeve may be solid or rod-like, or may be substantially hollow.
  • Sleeve 28 includes an opening 30 formed adjacent to the distal end of the sleeve, leaving a section of sleeve 32 between the distal tip of the sleeve and its opening 30.
  • Section 32 forms a ring-shaped portion encircling needle 4 which extends from distal end 12 of the sheath, through the distal tip of the sleeve. In its initial state, section 32 is positioned on manipulation end 24 so as to deform needle 4, thereby constraining the needle in recess 20 in its retracted position.
  • sleeve 28 slides toward the distal end of sheath 6, releasing the needle from section 32 and allowing needle 4 to assume its undeformed S-shaped configuration, thereby exposing the needle for use.
  • manipulation end 24 extends through opening 30, as well as through recess 20.
  • Device 2 may be returned to its initial state by sliding actuator 8 within sheath 6. With an actuation arrangement as described in the present invention, the device can be actuated with a short longitudinal stroke. A stop having cooperating surfaces on actuator 8 and sheath 6 prevents the actuator from being accidentally withdrawn completely from the sheath.
  • Manipulation end 24 of needle 4 terminates in a sharp point 34.
  • Manipulation end 24 includes means for slidably receiving and retaining a suture 36.
  • the means for slidably receiving and retaining suture 36 may be in the form of a hole 38, as seen in the Figs, or a notch, not shown.
  • the hole or notch is sized to accommodate sutures of varying diameters.
  • sharp point 34 is capable of piercing the tissue adjacent to the patient's wound when extended by actuator 8.
  • a thumb grip 40 is disposed at the proximal end of sleeve 8 for actuating in conjunction with gripping sections 18 of sheath 6.
  • puncture closure device 2 is introduced into a wound with suture 36 attached, as shown in Figs. 3, by threading suture 36 through hole 38 or notch) located in the manipulation end of the needle.
  • Device 2 is positioned within the wound such that sharp point 34 is beneath the tissue to be sutured.
  • Actuator 8 is then deployed by holding two fingers beneath gripping section 18 and using thumb grip 40 to push the gripping section and thumb grip relative to each other, so as to move needle 4 from a first position retracted within sheath 6, as seen in Fig. 3a, through an intermediate position as shown in Fig.
  • any gripping means could be employed for actuating the device, such as pistol grip, scissors action, screw mechanism or plunger mechanism.
  • sharp point 34 points in the proximal direction, toward actuator 8.
  • Device 2 is pulled upward, through tissue, from the internal layers to the external layers, driving sharp point 34 of needle 4 and suture 36 through one edge of the tissue surrounding the wound. A first portion of suture 36 is pulled through the tissue.
  • the device may be temporarily returned to the intermediate position shown in Fig. 3b to facilitate suture retrieval from the wound edge.
  • Device 2 is then pushed back through the tissue in the direction from external tissue to internal tissue, such that the needle is no longer piercing any tissue.
  • Suture 36 is still attached to needle 4.
  • Device 2 is rotated within the wound.
  • the device is again pulled upward, through the opposite edge of tissue, from internal layers to external layers, such that the other tissue edge of the wound is pierced with the sharp point of the needle, pulling the other end of suture 36 through the tissue.
  • the device may be again temporarily returned to its intermediate position as seen in Fig. 3b.
  • Suture 36 is removed from the needle, such that suture 36 is now completely free from device 2. Needle 4 is pushed back through the pierced tissue in the direction from external tissue to internal tissue, fully through the internal layer so that the sharp point of the needle is not piercing any tissue. Needle 4 may be returned to its retracted position such that section 32 of sleeve constrains the needle.
  • Device 2 is fully withdrawn from the wound. Suture 34 is tied.
  • the specific positions of Figs. 3a, 3b and 3c may be determined by any suitable means, for example a detent between the sheath and the sleeve.
  • Device 2 may be constructed with double needles, as shown in Figs. 4a-4c.
  • Fig. 4a illustrates double needles 4', 4" in the retracted position, moving through an intermediate position shown in Fig. 4b to Fig. 4c, which illustrates needles 4', 4" in the exposed position.
  • Actuation of the device may be achieved by a single actuator, as described above, or with the use of dual sleeves. Operation of the device is generally the same as that described in connection with the embodiment of Figs. 1-3.

Abstract

A surgical device (2) for closing trocar incision sites and delivering sutures (36). The present invention is a needle assembly (2) in which the needle (4) assembly is constructed of a spring-like material and initially housed within a sheath (6) in a deformed condition. The needle (4) can be easily exposed by sliding an actuator (8) so as to release the constraining means (32) and allow the needle (4) to assume its undeformed condition. The needle assembly (2) has few parts, allows a wide range for deflection of the needle (4), and the needle (4) may be exposed with a relatively short stroke.

Description

WOUND CLOSURE DEVTCR
This invention relates to a surgical instrument for closing the edges of a wound together with surgical sutures.
Backround of the Invention
Minimum invasive surgery generally includes the creation of trocar puncture wounds through the abdominal wall of a patient for insertion of a variety of surgical instruments. The structural strength of the abdominal wall is derived mostly from one or more layers of fascia disposed beneath the skin and between layers of muscle. Unless closed properly, the abdominal contents may herniate through these wounds, or body fluids can accumulate, promoting infection. Presently, surgeons attempt to close trocar puncture wounds using conventional needle drivers which are often cumbersome, making it difficult to properly close the wound.
Larger trocars (10mm and larger) are commonly used for surgical procedures. For large trocars and to avoid potential hernias, it is desirable to utilize flexible threads, or sutures, passing through apposing tissue edges tied to hold the more deeply buried portions of the edge of the wound together. Attempts have been made to address these problems, for example, in U.S. Patent Nos. 5,368,601 to Sauer et al; 5,374,275 to Bradley et al; and European Patent Application No. 0 634 141. However, these devices employ multiple needles, which result in a complex device which is complicated in use and expensive to manufacture.
U.S. Patent No. 5,403,328 to Shallman describes a surgical apparatus for closing a trocar incision. The Shallman device includes a curved needle pivotally positioned within a casing. The mechanism for pivoting the needle of Shallman is somewhat cumbersome, even while deflection of the needle is limited, and requires a long stroke to manipulate the needle. Summary of the Invention
I have designed a simple instrument for closing trocar incision sites and delivering sutures. The present invention is a needle assembly in which the needle is constructed of a spring-like material and initially housed within a sheath in a deformed condition. The needle can be easily exposed by sliding an actuator so as to release constraining means and allow the needle to assume its undeformed condition. The needle assembly has few parts, allows a wide range for deflection of the needle, and the needle may be exposed with a relatively short stroke.
A first aspect of the invention comprises a surgical device for suturing a wound in the tissue of a patient comprising: a sheath having a longitudinal axis including a proximal end and a distal end; a recess formed in the wall of said sheath toward said distal end; a needle constructed of a spring-like material, said needle being movable from a first retracted position wherein said needle is withdrawn into said recess to a second exposed position wherein said needle is extended from said recess; means for constraining said needle in its retracted position by deforming said needle; an actuator at said proximal end of said sheath for releasing said constraining means, so as to thereby allow said needle to assume its undeformed condition and move to said exposed position; said needle having a configuration such that upon extension from said distal end of said sheath, said needle points in the direction of said proximal end.
A further aspect of the invention comprises a surgical device for suturing a wound in the tissue of a patient comprising: a sheath having a longitudinal axis including a proximal end and a distal end; a recess formed in the wall of said sheath toward said distal end; a needle constructed of a shape memory alloy material comprising a generally S- shape and including a body and having one end fixedly attached to the interior of the distal end of said sheath, the body of said needle being movable in said sheath from a first position wherein said needle is retracted into said recess to a second position exposed wherein said needle is extended laterally from said recess; means for constraining said needle in its retracted; an actuator at said proximal end of said sheath for releasing said constraining means, said actuator comprising: a sleeve slidable within said sheath; an opening formed in the distal end of said sleeve through which said needle extends in the exposed position; wherein said means for constraining comprises a section of said sleeve formed between said opening and the distal end of said actuator such that upon release of said means for constraining said needle moves to said second, exposed position; said needle having a configuration such that upon extension from said distal end of said sheath, said needle points in the direction of said proximal end.
Brief Description of the Drawingfs^
Fig. 1 is a perspective view of the present invention. Fig. 2 is an exploded view of device of Fig. 1.
Figs. 3a, 3b and 3c are schematic views of deployment of the present invention. Figs. 4a, 4b and 4c are schematic views of a second embodiment of the present invention.
Description of the Preferred Embodiments
Referring now to the drawings, Fig. 1 illustrates a surgical device in the form of a puncture closure device 2 including a needle 4 movable in sheath 6. An actuator 8 is capable of moving needle 4 from a first, retracted position, as seen in Fig. 3a, to a second, exposed position, as seen in Figs. 1 and 3c. Device 2 is designed to be used in a sterile surgical field. The device may be disposable or reusable or partially disposable or reusable. The outer radial dimension of device 2 is 10mm or less.
Sheath 6 is a tubular sheath having a proximal end 10 and a distal end 12 disposed along opposite ends of longitudinal axis 14. Sheath 6 includes a blunt tip 16 located at the distal end and a gripping section 18 located at the proximal end. The advantage of a blunt end is to eliminate risk of inadvertent puncture of organs or tissue when inserting the device into a wound. A recess 20 is formed in the wall of the sheath adjacent to blunt tip 16 through which needle 4 may be extended, as seen in the Figures and as discussed below.
Needle 4 includes a body having a generally S-shaped configuration. A first end 22 of needle 4 is fixedly attached to the interior of the distal end of the sheath. Needle 4 may be fixedly attached to sheath 6 at end 22 by pins or other mechanical attachment, or may be formed with the sheath. The end opposite first end 22 of needle 4 is manipulation end 24, which includes a straightened portion 26. It should be noted, however, that the manipulation end may include a curved portion, rather than straightened portion 26. Needle 4 is constructed of a spring-like material. In its undeformed configuration, needle 4 assumes its S-shaped configuration exposed so that the S-shape extends from fixed end 22 through recess 20 to manipulation end 24. Straightened portion 26 is then generally parallel to longitudinal axis 14. In its deformed configuration, the needle is confined within recess 20. Needle 4 moves from its retracted position to its exposed position by operation of actuator 8. When manipulation end 24 is retracted within recess 20, puncture closure device 2 is in its retracted position. When the manipulation end is extended from recess 20, the puncture closure device is in the exposed position.
As discussed above, needle 4 may be constructed of a spring-like material, such as a shape memory alloy or stainless steel. The requirements are that the material be sufficiently resilient and bio-compatible. However, the needle is preferably constructed of a shape memory alloy, more preferably of superelastic material, and most preferably of an alloy including nickel titanium. With shape memory alloys, the radius of curvature of the S-shape can be smaller than with conventional materials, thereby permitting construction of a needle which has a configuration in which the manipulation end of the needle may be a greater distance from the sheath and in which the length of the S-shaped needle may be shorter.
Actuator 8 includes a sleeve 28 slidable within sheath 6. The proximal portion of the sleeve may be solid or rod-like, or may be substantially hollow. Sleeve 28 includes an opening 30 formed adjacent to the distal end of the sleeve, leaving a section of sleeve 32 between the distal tip of the sleeve and its opening 30. Section 32 forms a ring-shaped portion encircling needle 4 which extends from distal end 12 of the sheath, through the distal tip of the sleeve. In its initial state, section 32 is positioned on manipulation end 24 so as to deform needle 4, thereby constraining the needle in recess 20 in its retracted position. As actuator 8 is deployed, sleeve 28 slides toward the distal end of sheath 6, releasing the needle from section 32 and allowing needle 4 to assume its undeformed S-shaped configuration, thereby exposing the needle for use. In this position, manipulation end 24 extends through opening 30, as well as through recess 20. Device 2 may be returned to its initial state by sliding actuator 8 within sheath 6. With an actuation arrangement as described in the present invention, the device can be actuated with a short longitudinal stroke. A stop having cooperating surfaces on actuator 8 and sheath 6 prevents the actuator from being accidentally withdrawn completely from the sheath.
Manipulation end 24 of needle 4 terminates in a sharp point 34. Manipulation end 24 includes means for slidably receiving and retaining a suture 36. The means for slidably receiving and retaining suture 36 may be in the form of a hole 38, as seen in the Figs, or a notch, not shown. The hole or notch is sized to accommodate sutures of varying diameters. In any of these embodiments, sharp point 34 is capable of piercing the tissue adjacent to the patient's wound when extended by actuator 8.
A thumb grip 40 is disposed at the proximal end of sleeve 8 for actuating in conjunction with gripping sections 18 of sheath 6. In operation, puncture closure device 2 is introduced into a wound with suture 36 attached, as shown in Figs. 3, by threading suture 36 through hole 38 or notch) located in the manipulation end of the needle. Device 2 is positioned within the wound such that sharp point 34 is beneath the tissue to be sutured. Actuator 8 is then deployed by holding two fingers beneath gripping section 18 and using thumb grip 40 to push the gripping section and thumb grip relative to each other, so as to move needle 4 from a first position retracted within sheath 6, as seen in Fig. 3a, through an intermediate position as shown in Fig. 3b, to the exposed position as shown in Fig. 3 c. However, it is to be understood that any gripping means could be employed for actuating the device, such as pistol grip, scissors action, screw mechanism or plunger mechanism. At this point, sharp point 34 points in the proximal direction, toward actuator 8. Device 2 is pulled upward, through tissue, from the internal layers to the external layers, driving sharp point 34 of needle 4 and suture 36 through one edge of the tissue surrounding the wound. A first portion of suture 36 is pulled through the tissue. The device may be temporarily returned to the intermediate position shown in Fig. 3b to facilitate suture retrieval from the wound edge. Device 2 is then pushed back through the tissue in the direction from external tissue to internal tissue, such that the needle is no longer piercing any tissue. Suture 36 is still attached to needle 4. Device 2 is rotated within the wound. The device is again pulled upward, through the opposite edge of tissue, from internal layers to external layers, such that the other tissue edge of the wound is pierced with the sharp point of the needle, pulling the other end of suture 36 through the tissue. The device may be again temporarily returned to its intermediate position as seen in Fig. 3b. Suture 36 is removed from the needle, such that suture 36 is now completely free from device 2. Needle 4 is pushed back through the pierced tissue in the direction from external tissue to internal tissue, fully through the internal layer so that the sharp point of the needle is not piercing any tissue. Needle 4 may be returned to its retracted position such that section 32 of sleeve constrains the needle. Device 2 is fully withdrawn from the wound. Suture 34 is tied. The specific positions of Figs. 3a, 3b and 3c may be determined by any suitable means, for example a detent between the sheath and the sleeve. Device 2 may be constructed with double needles, as shown in Figs. 4a-4c. Fig. 4a illustrates double needles 4', 4" in the retracted position, moving through an intermediate position shown in Fig. 4b to Fig. 4c, which illustrates needles 4', 4" in the exposed position. Actuation of the device may be achieved by a single actuator, as described above, or with the use of dual sleeves. Operation of the device is generally the same as that described in connection with the embodiment of Figs. 1-3.
While the needle is described as being fixed to the sheath, it is within the scope of this invention to construct the device with the needle fixed to the distal end of the actuator, rather than the sheath. Variations and modifications can be made to the present invention without departing from the scope of the present invention, which is limited only by the following claims.

Claims

ClaimsWe claim:
1. A surgical device for suturing a wound in the tissue of a patient comprising: a sheath having a longitudinal axis including a proximal end and a distal end; a recess formed in the wall of said sheath toward said distal end; a needle constructed of a spring-like material, said needle being movable from a first retracted position wherein said needle is withdrawn into said recess to a second exposed position wherein said needle is extended from said recess; means for constraining said needle in its retracted position by deforming said needle; an actuator at said proximal end of said sheath for releasing said constraining means, so as to thereby allow said needle to assume its undeformed condition and move to said exposed position; said needle having a configuration such that upon extension from said distal end of said sheath, said needle points in the direction of said proximal end.
2. The surgical device as defined in claim 1 wherein said spring-like material is a shape memory alloy.
3. The surgical device as defined in claim 2 wherein said shape memory alloy is superelastic.
4. The surgical device as defined in claim 2 wherein said shape memory alloy is made from an alloy including nickel titanium.
5. The surgical device as defined in claim 1 wherein one end of said needle is fixedly attached to the interior of the distal end of said sheath.
6. The surgical device as defined in claim 1 wherein said actuator comprises: a sleeve slidable within said sheath; an opening formed in the distal end of said sleeve through which said needle extends in the exposed position; wherein said means for constraining comprises a section of said sleeve formed between said opening and the distal end of said actuator.
7. The surgical device as defined in claim 1 wherein in the exposed position, the needle extends outwardly of said sheath.
8. The surgical device as defined in claim 1 wherein in the exposed position, said needle is spaced from the longitudinal axis of said sheath.
9. The surgical device as defined in claim 1 wherein said needle configuration is an S-shape.
10. The surgical device as defined in claim 9 further including a straightened portion at a manipulation end of said needle such that said manipulation end is generally parallel to the longitudinal axis of said sheath.
11. The surgical device as defined in claim 1 wherein said sheath includes a blunt tip.
12. The surgical device as defined in claim 1 wherein said device includes a pair of needles.
13. The surgical device as defined in claim 1 further comprising means for receiving a suture.
14. A surgical device for suturing a wound in the tissue of a patient comprising: a sheath having a longitudinal axis including a proximal end and a distal end;a recess formed in the wall of said sheath toward said distal end; a needle constructed of a shape memory alloy material comprising a generally S- shape and including a body and having one end fixedly attached to the interior of the distal end of said sheath, the body of said needle being movable in said sheath from a first position wherein said needle is retracted into said recess to a second position exposed wherein said needle is extended laterally from said recess; means for constraining said needle in its retracted; an actuator at said proximal end of said sheath for releasing said constraining means, said actuator comprising: a sleeve slidable within said sheath; an opening formed in the distal end of said sleeve through which said needle extends in the exposed position; wherein said means for constraining comprises a section of said sleeve formed between said opening and the distal end of said actuator such that upon release of said means for constraining said needle moves to said second, exposed position; said needle having a configuration such that upon extension from said distal end of said sheath, said needle points in the direction of said proximal end.
15. The surgical device as defined in claim 14 wherein said needle is in a deformed condition in the retracted position and assumes its undeformed condition in the exposed position.
16. The surgical device as defined in claim 14 wherein said body of said needle includes a straightened portion at a manipulation end of said needle such that said manipulation end of said needle is generally parallel to the longitudinal axis of said sheath in said exposed position.
17. The surgical device as defined in claim 14 wherein said sheath includes a blunt tip.
18. The surgical device as defined in claim 14 wherein said device includes a pair of needles.
19. The surgical device as defined in claim 14 further comprising means for receiving a suture.
PCT/US1996/007318 1995-06-07 1996-05-20 Wound closure device WO1996039946A1 (en)

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JP50062997A JP3729861B2 (en) 1995-06-07 1996-05-20 Wound closure device
DE69622969T DE69622969T2 (en) 1995-06-07 1996-05-20 WOUND CLOSURE DEVICE
AT96916518T ATE222076T1 (en) 1995-06-07 1996-05-20 WOUND CLOSURE DEVICE
EP96916518A EP0774922B1 (en) 1995-06-07 1996-05-20 Wound closure device

Applications Claiming Priority (2)

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US47461395A 1995-06-07 1995-06-07
US08/474,613 1995-06-07

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EP (1) EP0774922B1 (en)
JP (1) JP3729861B2 (en)
AT (1) ATE222076T1 (en)
CA (1) CA2197066A1 (en)
DE (1) DE69622969T2 (en)
WO (1) WO1996039946A1 (en)

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US5817108A (en) 1998-10-06
EP0774922B1 (en) 2002-08-14
EP0774922A1 (en) 1997-05-28
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US6113610A (en) 2000-09-05
DE69622969T2 (en) 2003-04-24
DE69622969D1 (en) 2002-09-19

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